Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury

Taichung Tzu Chi Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Brain Injury

Treatments: Drug: Wendan decoction combination in acute brain injury

Study type: Interventional

Funder types: Other

Identifiers

NCT03851809

REC103-26

Details and patient eligibility

About

Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - A randomized controlled study.

Full description

This study adopted a prospective, randomized controlled design. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in this study and randomized into intervention group and control group. All patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. The intervention group mean regular neuro-intensive care combined TCM and the intervention group mean only neuro-intensive care. But there are 7 patients in intervention group and 12 patients in control group quit out this study

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset;
• an initial score of 3-12 points of GCS score;
• adults between 18 to 80 years old;
• and signed informed consent form.

Exclusion criteria

• after 14 days of onset;
• a history of previous TBI or stroke;
• intracranial aneurysm or arteriovenous malformation ruptured;
• combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels);
• other severe disease such as heart or kidney failure;
• previous diagnosed cancer; and pregnant women.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

neurologic intensive care in acute brain injury

Experimental group

Description:

With the guidance of Taiwan Neurosurgical Society and Taiwan Neurological Society, patients in the control group were given the consistent treatment. (http://www.neurosurgery.org.tw/nsr/tbi/main.htm and http://www.stroke.org.tw/guideline/guideline_1.asp). The intensive treatments were established according to the traumatic brain injury treatment guidelines and spontaneously intracerebral hemorrhage general treatment principles from these two society in Taiwan.

Treatment:

Drug: Wendan decoction combination in acute brain injury